NKT5097 for Cancer

Recruiting at 7 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: NiKang Therapeutics, Inc.

Disqualifiers: Curative tumor, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

205 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, NKT5097, for individuals with advanced or metastatic tumors, specifically targeting breast cancer and tumors with a CCNE1 gene amplification. The main goal is to determine the safest dose and understand any side effects participants might experience. The trial consists of three parts: dose determination, testing with food, and dose expansion based on safety. This trial may suit those with solid tumors that cannot be removed or treated with current options and who can manage daily life independently. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that NKT5097 is likely to be safe for humans?

Research shows that NKT5097 could be a promising treatment for adults with advanced tumors. Researchers are testing this treatment to determine its safety and tolerability. Early results suggest that NKT5097 might not cause common side effects like low white blood cell count (neutropenia) and diarrhea, which often occur with similar cancer treatments. This is because NKT5097 targets specific proteins, CDK1 and CDK6, more accurately. However, as NKT5097 is a new drug still in early testing stages, detailed safety information remains limited. Study participants will help researchers learn about possible side effects and identify the best dose to use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about NKT5097 for cancer because it offers a novel approach compared to current treatments like chemotherapy and targeted therapies. NKT5097 is unique because it is an orally administered drug, which may offer more convenience and ease of use compared to intravenous options. Additionally, the trial explores how NKT5097 works with and without food, potentially optimizing its effectiveness and absorption. This drug has the potential to target cancer cells more precisely, possibly leading to fewer side effects and improved outcomes for patients.

What evidence suggests that NKT5097 might be an effective treatment for cancer?

Research shows that NKT5097 is a promising new treatment for advanced or spreading tumors. It targets and breaks down specific proteins, CDK2 and CDK4, which help tumors grow. This targeted action might slow or stop cancer cell growth. Although results on its effectiveness in people are not yet available, the treatment's unique approach offers hope. Early data on the drug's effects suggest that it effectively reaches its target. Participants in this trial will receive NKT5097 in different study phases, including dose escalation, food effect, and dose expansion, to evaluate its safety and effectiveness. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic solid tumors, particularly those with breast cancer and tumors showing CCNE1 amplification. Participants must meet certain health criteria to join.

Inclusion Criteria

Able to provide written informed consent

Patients who are capable of insemination must be willing to use highly effective contraception and to refrain from sperm donation during treatment and for 28 days after the last dose

Willing to provide tumor tissue

Exclusion Criteria

I have had uveitis, retinopathy, or significant eye disease.

I have not had major surgery in the last 30 days.

I am still experiencing side effects from my previous cancer treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of NKT5097 to determine safety and tolerability

Varies based on dose levels

Food Effect Analysis

Participants receive NKT5097 with and without food to evaluate the effect of food on drug absorption

Varies based on cohort

Tumor-specific Expansion

Participants are enrolled into tumor-specific cohorts to further evaluate safety and efficacy

Varies based on cohort

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NKT5097

Trial Overview The study is testing NKT5097, a CDK2/CDK4 dual degrader, in patients with specific types of cancer. It's an open-label trial that aims to find the safest and most effective dose for future phases.

How Is the Trial Designed?

Group I: Part 3 Expansion Experimental Treatment 1 Intervention

Expansion of dose levels based upon safety and PK following Part 1 escalation.

Group II: Part 2 Food Effect Experimental Treatment 1 Intervention

Orally administered NKT5097 with and without meal

Group III: Part 1 Dose Escalation Experimental Treatment 1 Intervention

Escalation of orally administered NKT5097

Who Is Running the Clinical Trial?

NiKang Therapeutics, Inc.

Lead Sponsor

Trials

5

Recruited

1,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07029399

NCT07029399 | A Study With NKT5097 for Adults ... The goal of this open-label dose escalation and expansion study is to evaluate the safety and tolerability of NKT5097 in adults with advanced/metastatic tumors.

2. biospace.com biospace.com/press-releases/nikang-therapeutics-completes-dosing-of-the-first-cohort-in-a-phase-1-study-of-nkt5097-a-first-in-class-highly-potent-and-selective-orally-bioavailable-cdk2-4-dual-degrader

NiKang Therapeutics® Completes Dosing of the First ... NKT5097 is a first-in-class, orally bioavailable small molecule designed to selectively degrade CDK2 and CDK4 simultaneously, offering potential ...

3. dana-farber.org dana-farber.org/clinical-trials/25-331

A Phase 1, First-in-Human, Open-Label Study to Evaluate ... The goal of this open-label dose escalation and expansion study is to evaluate the safety and tolerability of NKT5097 in adults with advanced/metastatic ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT07029399/a-study-with-nkt5097-for-adults-with-advanced-metastatic-solid-tumors

A Study With NKT5097 for Adults With Advanced/Metastatic ... The goal of this open-label dose escalation and expansion study is to evaluate the safety and tolerability of NKT5097 in adults with advanced/metastatic tumors.

5. healthscout.app healthscout.app/trial_match/view_trial/NCT07029399/?back=/trial_match/view_trials/condition/breast/%3Fpage%3D29

Trial: A Study With NKT5097 for Adults With Ad… - HealthScout Efficacy. No human efficacy outcomes (e.g., response rates) have been reported publicly as of October 7, 2025. Early pharmacodynamic data ...

6. businesswire.com businesswire.com/news/home/20250908965353/en/NiKang-Therapeutics-Completes-Dosing-of-the-First-Cohort-in-a-Phase-1-Study-of-NKT5097-a-First-in-Class-Highly-Potent-and-Selective-Orally-Bioavailable-CDK24-Dual-Degrader

NiKang Therapeutics® Completes Dosing of the First ... Due to its superior selectivity against CDK1 and CDK6, NKT5097 has the potential to mitigate neutropenia and/or diarrhea associated with ...

7. breastcancertrials.org breastcancertrials.org/bct_nation/mts/mtsResult.seam?zip=94107&searchTerm1=NCT07029399

MTS Trials - BreastCancerTrials.org Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of NKT5097, an experimental CDK2/4 degrader. Who is this for?: